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Title:  Intravenous valproate for acute treatment of migraine headache
United States Patent: 
7,163,689
Issued: 
January 16, 2007

Inventors: 
Edwards; Keith R., N/A (Bennington, VT)
Appl. No.: 
11/173,922
Filed: 
July 1, 2005


 

Executive MBA in Pharmaceutical Management, U. Colorado


Abstract

The present invention features a novel therapy for effecting acute treatment of migraine headache. The therapy involves intravenous administration of valproate and is equal to and in some respects superior to previously-known therapies for abortive treatment of prolonged moderate to severe acute migraine headache.

Description of the Invention

BACKGROUND OF THE INVENTION

Migraine headache is a chronic and disabling condition affecting a significant portion of the population throughout the world. The pharmacologic management of migraine has traditionally focused on two approaches: symptomatic or acute treatment and prophylactic therapy. The objective of acute treatment is to reduce the intensity and duration of pain with its attendant symptoms and to optimize the patient's ability to function normally whereas the major objective of prophylactic therapy is the reduction of frequency, duration, and intensity of attacks.

A variety of treatment strategies are available for the prophylactic treatment of migraines including beta-blocking drugs (e.g., propranolol), amitriptyline, flunarizine, serotonin antagonists (e.g., methysergide) and nonsteroidal anti-inflammatory drugs (e.g., naproxen) are the major classes of agents that have been used in the prophylactic treatment of migraines. See e.g., Deleu et al (1998) Clin. Neuropharmacol. 21:267 79 for review. Strategies for the acute treatment of migraines are also known which generally involve the use of simple analgesics, nonsteroidal anti-inflammatory drugs, antiemetics, narcotic analgesics, ergot derivatives, or serotonin-agonists, either alone or in combination. For example, dihydroergotamine (DHE) has been used for several decades for treatment of acute migraine headache and produces good relief in 70 80% of subjects at 2 hours after administration (Callaham and Raskin (1986) Headache 26;168 171). Sumatriptan produces similar efficacy, as do several newer serotonin 1B/1D receptor agonists (Cady et al. (1991) JAMA 265:2831 2835; Mathew et al. (1992) Arch Neurol. 49:1271 1276 and Rapoport (1997) Cephalalgia 17: 464 465).

However, a significant portion of migraine patients remain who either require narcotic analgesic treatment or who may have significant disability despite the use of non-narcotic analgesia. A large number of patients go to hospital emergency rooms for acute treatment of prolonged migraine headache (Klapper et al. (1991) 31:523 524). Many of those patients may have used an ergotamine or triptan so that use of DHE, injectable sumatriptan or other related compounds would be contraindicated. Also, cardiovascular risk factors limit the safety of triptan use or dihydroergotamine; the new DHE nasal spray (Migranal) carries the same warnings as the triptans. (Kelly (1995) Neurology 45:11 13; Maxalt:MSD, Ltd. (1998) Insert; and Physician's Desk Reference, 53 Edition, Medical Economics Comp. (1999) pp 2061). Finally, a number of patients presenting to the emergency room have associated analgesic rebound headache, with or without chronic daily headache, in which cases further analgesic use is problematic (Silberstein and Young (1995) Drug Saf. 13:133 144).

SUMMARY OF THE INVENTION

This invention is based on the discovery of an effective acute treatment for migraines which involves intravenous injection of valproate sodium, also referred to herein according to its tradename, Depacon.TM.. In particular, it has been discovered that intravenous valproate is an alternative therapy for abortive treatment of moderate to severe prolonged acute migraine headache.

DETAILED DESCRIPTION AND EXEMPLIFICATION

The present invention describes the results of studies using intravenous valproate ("VPA") for abortive treatment of acute migraine headache. The present studies were designed, in particular, to determine the possible effectiveness of intravenous administration of VPA for the treatment of acute migraine headache of significant duration. Accordingly, the invention provides methods of treating acute migraine headache in an subject in need of treatment. In one embodiment, the method involves administering to the subject an effective dose of intravenous valproate. Administration of intravenous valproate is preferably such that the severity and/or duration of acute migraine headache is lessened or reduced. Alternatively, administration is such that a symptom selected from the group consisting of nausea, photophobia, and phonophobia is lessened or reduced. In a preferred embodiment, about 100 mg to 2000 mg valproate are administered to a subject. Preferably about 200 mg to 1500 mg are administered, more preferably about 300 mg to 1000 mg are administered, and even more preferably about 250 mg to 750 mg of valproate are administered. In a particularly preferred embodiment, about 500 mg valproate are administered to the subject. In another embodiment, the valproate administered to the subject is administered over 1 hour. In yet another embodiment, the valproate is administered to a subject over 30 minutes. In yet another embodiment, the valproate is administered to a subject over 30 minutes to 1 hour. In yet another embodiment, the valproate is administered to a subject over 15 minutes to 30 minutes. In yet another embodiment, the valproate is administered to a subject over 5 minutes to 15 minutes. In yet another embodiment, the valproate is administered to a subject over 1 minute to 5 minutes. In yet another embodiment, the valproate is administered to the subject in more than one dose.
 

 

Claim 1 of 9 Claims

1. A method of treating acute migraine headache in an subject comprising administering to the subject an effective dose of intravenous valproate such that acute migraine headache is lessened or reduced in said subject, wherein about 250 mg to 750 mg of valproate is administered to a subject over 30 minutes to 1 hour.

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If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.

 

 

     
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